--- title: "ISO/TR 24971, Definition | MedTech Terms" description: "Guidance on the application of ISO 14971 to medical devices. 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[Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ISO/TR 24971 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system) # ISO/TR 24971 Guidance on the application of ISO 14971 to medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO/TR 24971:2020 provides guidance on developing, implementing, and maintaining a risk management system per [ISO 14971](/terms/iso-14971), including hazard identification, risk control, residual risk evaluation, and post-production information. What the regulation says ISO/TR 24971:2020 offers supplementary guidance to [ISO 14971](/terms/iso-14971):2019, providing practical methods and examples for establishing, documenting, and maintaining a risk management system. While not a normative standard itself, regulators and notified bodies expect manufacturers to consider its recommendations for demonstrating conformity to risk management requirements, such as those in EU [MDR](/terms/mdr-reporting) Annex I Chapter I Section 3. ## What this means in practice TR 24971 is the de facto playbook for executing [ISO 14971](/terms/iso-14971) in practice and is frequently referenced by auditors and notified bodies. ## Examples - A MedTech manufacturer uses the guidance in ISO/TR 24971 section 6.2, 'Risk analysis techniques,' to select appropriate methodologies for identifying hazards and estimating risks for a new surgical robot. - During a notified body audit for CE marking, a manufacturer references specific examples from ISO/TR 24971 regarding risk control measures to justify their approach to mitigating software cyber risks in their diagnostic imaging system. - A quality manager consults ISO/TR 24971 Annex C, 'Guidance on safety-related information,' to improve their post-market surveillance process for collecting and analyzing field data relevant to risk management. Common pitfalls - • A common pitfall is treating ISO/TR 24971 as a standalone requirement rather than as guidance for implementing ISO 14971. - • Manufacturers sometimes fail to periodically review and update their risk management processes based on the evolving recommendations in ISO/TR 24971. - • Overlooking the interconnectedness between risk management activities and other quality system elements, such as design control or post-market surveillance, is a frequent mistake. ## Frequently asked questions Is ISO/TR 24971 a normative standard? No, ISO/TR 24971 is a technical report providing guidance, not a normative standard with auditable requirements. Its purpose is to aid in the effective application of [ISO 14971](/terms/iso-14971):2019. How does ISO/TR 24971 relate to ISO 14971? Should manufacturers specifically document compliance with ISO/TR 24971? ## Cross-references ### See also Closely related context worth reading. - [ ISO 14971 ](/terms/iso-14971) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971)[ Quality & Risk Risk Management File(RMF) Set of records and outputs from the ISO 14971 risk management process. ](/terms/risk-management-file) ### More in Standards · Same category [ Standards ASTM F2503 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. ](/terms/astm-f2503)[ Standards Essential Performance Performance of a clinical function whose loss or degradation would result in unacceptable risk. ](/terms/essential-performance)[ Standards ICH E6(R3) Good Clinical Practice(E6(R3)) Revision 3 of the ICH Good Clinical Practice guideline, restructured around principles, modernized for risk-based and decentralized trials, finalized in 2023. ](/terms/ich-e6-r3)[ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 FDA· 1 1. [1 ISO/TR 24971:2020 Verified ISO · iso.org ](https://www.iso.org/standard/74437.html) 2. [2 FDA Recognized Consensus Standards Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) 3. [3 ISO Standards Catalogue - Health Verified ISO · iso.org ](https://www.iso.org/ics/11/x/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Implementing this standard on a device program? Blue Goat Cyber helps MedTech teams operationalize cybersecurity standards across the design and post-market lifecycle. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Standards Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=tr24971) Learn in 60 seconds Card Lesson Quiz Guidance on the application of ISO 14971 to medical devices. - · TR 24971 is the de facto playbook for executing ISO 14971 in practice and is frequently referenced by auditors and notified bodies. Remember this Watch out: A common pitfall is treating ISO/TR 24971 as a standalone requirement rather than as guidance for implementing ISO 14971. Related terms - [ISO 14971 ](/terms/iso-14971) - [Risk Management File(RMF) ](/terms/risk-management-file) You may also need Auto-suggested from Standards and shared keywords. - [ISO/IEC 23894 ](/terms/iso-iec-23894) - [AAMI TIR57 ](/terms/aami-tir57) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [ISO/IEC 27001(ISO 27001) ](/terms/iso-27001) - [Post-Production Information (Risk) ](/terms/post-production-info) [All Standards terms](/terms?cat=Standards) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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